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    Summary
    EudraCT Number:2016-004574-17
    Sponsor's Protocol Code Number:CC-220-SLE-002
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-04-21
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2016-004574-17
    A.3Full title of the trial
    A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLEBLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-220 IN SUBJECTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to measure how safe CC-220 is and how well CC-220 works in people with lupus.
    A.4.1Sponsor's protocol code numberCC-220-SLE-002
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03161483
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1195-7804
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCelgene Corporation
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCelgene Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCelgene Corporation
    B.5.2Functional name of contact pointClinicalTrialDisclosure
    B.5.3 Address:
    B.5.3.1Street Address9225 Indian Creek Parkway, Suite 900
    B.5.3.2Town/ cityOverland Park, Kansas
    B.5.3.3Post code66210
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1888260 1599
    B.5.5Fax number+1913266 0394
    B.5.6E-mailClinicalTrialDisclosure@celgene.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code CC-220
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCC-220
    D.3.9.3Other descriptive nameCC-220
    D.3.9.4EV Substance CodeSUB179693
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.15
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code CC-220
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCC-220
    D.3.9.3Other descriptive nameCC-220
    D.3.9.4EV Substance CodeSUB179693
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.3
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code CC-220
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCC-220
    D.3.9.3Other descriptive nameCC-220
    D.3.9.4EV Substance CodeSUB179693
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.45
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    SYSTEMIC LUPUS ERYTHEMATOSUS
    E.1.1.1Medical condition in easily understood language
    Heterogeneous, inflammatory, multisystem autoimmune disease in which antinuclear antibodies occur. "Lupus erythematosus" describes the typical rash of SLE.
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10025134
    E.1.2Term Lupus erythematosus
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the clinical efficacy of three doses of CC-220 (0.45 mg once per day [QD], 0.3 mg QD or 0.15 mg QD) compared to placebo, for the treatment of active systemic lupus erythematosus (SLE) using the SLE Responder Index at Week 24, defined as:
    - Reduction from baseline of ≥ 4 points in the SLEDAI 2K and
    - No new one or more British Isles Lupus Assessment Group (BILAG) A or new* 2 or more BILAG B items compared to baseline using BILAG 2004 Index and
    - No worsening from baseline defined by an increase of < 0.30 points from baseline on a Physician's Global Assessment (PGA) visual analog scale (VAS) from 0-3
    *new excludes A to B
    E.2.2Secondary objectives of the trial
    Week 24
    - To evaluate additional measures of clinical disease activity of CC-220 (0.45 mg once per day [QD], 0.3 mg QD or 0.15 mg QD) compared to placebo for the treatment of subjects with active SLE
    - To assess the reduction in steroid use
    - To evaluate the safety and tolerability of 0.45 mg QD, 0.3 mg QD, and 0.15 mg QD of CC-220 compared to placebo in subjects with active SLE
    Week 52
    -To evaluate additional measures of clinical disease activity and maintenance of effect of CC-220 (0.45 mg once per day [QD], 0.3 mg QD or 0.15 mg QD) for the treatment of subjects with active SLE
    - To assess the reduction in steroid use
    - To evaluate the longer term safety and tolerability of 0.45 mg QD, 0.3 mg QD, and 0.15 mg QD of CC-220 in subjects with active SLE
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Male or female 18 years of age or older at the time of signing the informed consent.
    •Understand and voluntarily sign informed consent forms (ICFs) prior to the initiation of any study specific assessments/procedures.
    •Able and willing to adhere to the visit schedule and other protocol requirements.
    Disease Specific
    •Have a diagnosis of SLE for at least 6 months prior to the Screening Visit and fulfill the 1997 update of the 1982 American College of Rheumatology (ACR) Classification Criteria for SLE at the Screening Visit.
    •At the Screening Visit a SLEDAI 2K score of ≥ 6 points, at least four points of which are a "clinical" SLEDAI 2K score. The “clinical” score is the SLEDAI 2K assessment score without the inclusion of points attributable to any urine or blood laboratory results including immunologic measures. Neurologic descriptors of the SLEDAI 2K (items 1-7) are not counted towards the SLEDAI study entry criteria.
    •At the Baseline Visit, a clinical SLEDAI 2K score of ≥ 4 points.
    •Positive antibodies associated with SLE, which must include at least one of the following within the Screening Phase:
    Positive antinuclear antibody (ANA) test at the central laboratory with a titer of 1:80 or greater, associated with a diagnosis of SLE,
    Anti-dsDNA antibodies elevated to above normal as per the central laboratory,
    Anti-Smith (anti-Sm) antibody elevated to above normal as per the central laboratory.
    Pregnancy
    All male and female subjects should be counseled about pregnancy precautions and risks of fetal exposure as described in the Pregnancy Prevention Plan (provided separately).
    •Females of childbearing potential (FCBP) must:
    - Have two negative pregnancy tests as verified by the Investigator prior to starting study therapy, one within 10 to 14 days prior to the first dose of CC-220 and again within 24 hours before taking the first dose of CC-220. She must agree to ongoing pregnancy testing during the course of the study, and after end of study treatment. This applies even if the subject practices true abstinence from heterosexual contact.
    - Either commit to true abstinence from heterosexual contact (which must be reviewed on a monthly basis and source documented) or agree to use two forms of reliable contraception simultaneously. One must be a highly effective method and one additional effective (barrier) method, and both must be practiced without interruption, 28 days prior to starting investigational product, during the study therapy (including dose interruptions), and for 28 days after discontinuation of study therapy.
    - Male subjects must: Practice true abstinence or agree to use a barrier contraception (male latex condom or non-latex condom NOT made out of natural [animal] membrane [for example, polyurethane]) during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 90 days following investigational product discontinuation, even if he has undergone a successful vasectomy.
    •Male subjects must agree not to donate semen or sperm during therapy and for at least 90 days following the discontinuation of IP.
    •All subjects must:
    - Understand that the IP could have potential teratogenic risk.
    - Agree to abstain from donating blood while taking IP and for 28 days following discontinuation of the IP.
    - Agree not to share IP with another person.
    - Other than the subject, FCBP and males able to father a child should not handle the IP or touch the capsules unless gloves are worn.
    - Be counseled about pregnancy precautions and risks of fetal exposure as described in the Pregnancy Prevention Plan.
    Concomitant Medications
    •If taking steroids, subjects must be on oral corticosteroids (OCS) for at least 4 weeks prior to the Screening Visit, and maintained on a stable dose of ≤ 20 mg/d of prednisone or equivalent for at least 2 weeks prior to the Baseline Visit.
    •If taking hydroxychloroquine, quinacrine, chloroquine, methotrexate, leflunomide, sulfasalazine, mycophenolate mofetil, mycophenolic acid, azathioprine, 6-mercaptopurine, tacrolimus or cyclosporine, subjects must have been treated for 12 weeks prior to and be on a stable dose for at least 4 weeks prior to Baseline. NOTE: For subjects not taking, or are on unstable doses of antimalarials, methotrexate, sulfasalazine, leflunomide, tacrolimus, cyclosporine A, azathioprine, 6-mercaptopurine or mycophenalate, the last dose (in case of previous use) must be at least 8 weeks prior to the Baseline Visit.
    •Subjects taking daily doses of NSAIDs must be on a stable dose two weeks prior to the Screening Visit. Subjects taking NSAIDs or analgesics on an as needed basis must hold them 72 hours prior to the Baseline Visit.
    E.4Principal exclusion criteria
    1.The subject has received:
    a.Cyclophosphamide within 3 months of the Baseline Visit. Previous use of Melphalan or other alkylating agents is prohibited.
    b.Etanercept within 4 weeks prior to the Baseline Visit.
    c.Belimumab within 3 months prior to the Baseline Visit.
    d.B-cell depleting or modulating agents, such as rituximab or anti-CD22 therapy, within one year prior to the Baseline Visit.
    e.Any other biologic or non-biologic immunosuppressive agent within 2 months of 5 pharmacokinetic half-lives (whichever is longer) prior to the Baseline Visit.
    2.The subject has been treated with intra-articular, intralesional, subcutaneous, intradermal, intramuscular or IV pulse corticosteroids 6 weeks prior to the Baseline Visit.
    3.The subject has received high potency topical corticosteroids within two weeks of the Screening Visit (only Class 6 or 7 are permitted).
    4.The subject has undergone plasmapheresis within 3 months of the Baseline Visit.
    5.The subject has received IV immunoglobulin within 3 months of the Baseline Visit.
    6.The subject has received strong inhibitors or inducers of CYP3A4/5 including grapefruit, St. John’s Wort or related products within two weeks prior to the Baseline Visit.
    7.The subject has a planned or received immunization with a live or live attenuated vaccine within 2 months prior to the Baseline Visit and for 2 months after administration of the last dose of IP.
    Disease Severity
    8.The subject has severe lupus nephritis defined as: estimated glomerular filtration rate (eGFR) of < 45 mL/1.73 m2 or proteinuria > 2000 mg/day if stable for the past 3 months, or proteinuria > 500 mg/day if unstable. Proteinuria will be based upon spot urine testing.
    9.The subject has active, severe or unstable neuropsychiatric lupus disease (e.g., poorly controlled seizure disorder, acute confusional state, myelitis, stroke or stroke syndrome, cerebellar ataxia or dementia related to SLE, psychosis, organic brain syndrome, cerebrovascular accident [CVA], cerebritis or CNS vasculitis), within 6 months of the Screening Visit.
    Concomitant Disease
    10.The subject has QTcF of > 450 milliseconds.
    11.The subject has a history of hepatitis B and/or hepatitis C.
    12.The subject has a confirmed positive test for Hepatitis B or Hepatitis C during the Screening Phase. Subjects with isolated positive hepatitis B surface antibody are not excluded.
    13.The subject has a history of congenital and/or acquired immunodeficiencies (eg, common variable immunodeficiency, human immunodeficiency virus [HIV], etc).
    14.The subject has active or history of recurrent bacterial, viral, fungal, mycobacterial or other infections, or any major episode of infection requiring hospitalization or treatment with intravenous or oral antibiotics within 4 weeks of the Screening Visit and at any time during the Screening Phase, up through the first dose of IP.
    15.The subject has a history of latent or active TB, unless there is medical record documentation of successful completion of a standard course of treatment per local guidelines.
    16.The subject has an abnormal chest radiograph with evidence of active infection or possible malignancy. Alternatively, PA or PA/lateral radiographs that were taken within the 3 months (or longer periods based on local health authority requirements) prior to the Screening Visit will be accepted for evaluation for participation in the study.
    17.The subject has malignancy or history of malignancy, except for:
    •treated (eg, cured) basal cell or squamous cell in situ skin carcinomas
    •treated (eg, cured) cervical intraepithelial neoplasia or carcinoma in situ of the cervix with no evidence of recurrence within 5 years of the Screening Visit.
    18.The subject has a diagnosis or history consistent with Antiphospholipid Syndrome.
    19.History of arterial or venous thrombosis, unless on appropriate anticoagulation for at least 6 months prior to Baseline Visit & throughout the study.
    20.The subject has a history or current diagnosis of peripheral neuropathy (sensory or motor) ≥ Grade 2.
    21.The subject has a presence of active uveitis or any other ophthalmological finding that in the opinion of the Investigator is clinically significant.
    22.The subject has dermatomyositis, polymyositis, scleroderma, rheumatoid arthritis or other non-SLE driven inflammatory joint or skin disease or overlap syndromes as the primary disease.
    23.Laboratory criteria:
    •Neutrophil count < 1.0 x 109/L
    •White blood cell (WBC) count ≤ 2500 /µL (≤ 2.5 X 109/L) or > 20,000/µL (> 20 X 109/L)
    •Lymphocyte count ≤ 500/mm3 or 0.5 x 109/L
    •Platelet count ≤ 75 x 109/L and > 550 x 109/L
    •Hemoglobin < 8g/dL or > 18 g/dL
    •Serum creatinine > 1.8 mg/dL (> 159.12 µmol/L)
    •Total bilirubin > 2 x ULN
    •Aspartate transaminase (AST [serum glutamic oxaloacetic transaminase, SGOT]) > 2 x upper limit of normal (ULN)
    •Alanine transaminase (ALT [serum glutamic pyruvic transaminase, SGPT]) > 2 x upper limit of normal (ULN)
    E.5 End points
    E.5.1Primary end point(s)
    SRI(4) response
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 24
    E.5.2Secondary end point(s)
    SRI(4)
    SLEDAI 2K
    CLASI
    BILAG
    Joint Counts
    PGA
    Fatigue
    BILAG
    Corticosteroid Reduction
    Flare
    SLE Damage
    E.5.2.1Timepoint(s) of evaluation of this end point
    SRI(4): Week 52
    SLEDAI 2K: Week 24 and Week 52
    CLASI: Week 24 and Week 52
    BILAG: Week 24 and Week 52
    Joint Counts: Week 24 and Week 52
    PGA: Week 24 and Week 52
    Fatigue: Week 24 and Week 52
    BILAG: Week 24 and Week 52
    Corticosteroid Reduction: Week 24 and Week 52
    Flare: All visits
    SLE Damage: Week 52
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA43
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Belgium
    Brazil
    Canada
    Colombia
    Germany
    Hungary
    Italy
    Mexico
    Poland
    Russian Federation
    Serbia
    Spain
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The End of Trial is defined as either the date of the last visit of the last subject to complete the post-treatment follow-up, or the date of receipt of the last data point from the last subject that is required for primary, secondary and/or exploratory analysis, as pre-specified in the protocol, whichever is the later date.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 250
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 97
    F.4.2.2In the whole clinical trial 280
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    A long-term extension study is planned to be implemented to provide CC-220 for those subjects who derived benefit from CC-220 during the CC-220-SLE-002 study and for whom it is medically appropriate to continue to receive drug.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-07-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-09-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-08-03
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